Regulatory Document Management System
Electronic Document Management System
The flagship product of the eIT Project Management Office, EDMS is a web-based enterprise management and business process automation system certified with DOD 5015.02 that allows users to collaborate both within and across organizations.
Electronic Common Technical Document
The eCTD allows users to prepare applications using a globally mandated structure for regulatory submissions originating from Office of the Surgeon General /Army and DHA-sponsored investigational product development.
FDA Study Data Validator
Provides a study data validation capability that is compliant with the Clinical Data Interchange Standards Consortium. The FDA SDV accelerates the submission process and ensures data validation and integrity of the clinical and non-clinical datasets for electronic submission to the FDA.
Clinical Operations Management System
Electronic Data Capture-Clinical Research Data Management System
This system supports the full life cycle of clinical studies from study inception through data entry, cleaning, validation, reporting, and study close-out. EDC streamlines the conduct of clinical trials while providing greater visibility of analysis and submissions.
Serious Adverse Event System
The SAE system is crucial to ensuring patient safety, maintaining Force readiness, and improving effectiveness, efficiency, and regulatory compliance with real-time reporting of the adverse event.
Laboratory Information Management System
The LIMS provides management of laboratory information in support of FDA regulated and non-regulated research, and includes the management of laboratory data, workflows, and products. This system enables users to perform several key functions, including the following:
- Manage biorepository samples and laboratory products across their entire lifespan
- Manage consumables inventory with automated updating and notifications
- Track usage, maintenance, and calibration of instruments and their parts
- Generate and print barcodes for samples, plates, instruments, and consumables
- Search system-wide information through Ad Hoc Query tools
